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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powered insertion system for a cochlear implant electrode array
Definition A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.
Product CodeQQH
Regulation Number 874.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
IOTAMOTION, INC.
  GRANTED 1

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